הכשרות וסמינרים

Lecturer: Ian Flaherty Sr. Product Manager; Proveris Scientific

Abstract:

Drug Development in the orally inhaled and nasal drug product (OINDP) space presents many complex problems, all needing to be tackled accordingly, in order to reach the product approval stage. Depending on the target market for the product, the regulatory landscape can be difficult to navigate, and settling on the right path is an important decision with huge financial implications. With any combination drug product, developers must fully consider and understand the relationships between drug formulation, device performance, and patient usage. In this talk, we will highlight some of the key challenges in OINDP development and explain how to spray pattern measurements are used as key critical quality attributes (CQAs) to evaluate the process and material parameters for product development. We will outline the Quality By Design (QbD) approach and speak to how automated actuation and Proveris’ SprayVIEW® technology can help accelerate project timelines.

Lecturer: Dr. Robert Taylor & Dr. John Ddungu; Malvern Panalytical

Abstract:

Drug product developers face many challenges as they seek to develop new drug products based on novel dosage forms or delivery technologies. This particularly  true of Orally Inhaled and Nasal Drug Products (OINDPs), where developers must not only develop an effective formulation but also understand how this can be reproducibly delivered to a patient using a complex device. As a result, the development of new and generic OINDPs is considered high risk, with many projects failing to meet project timescales or even reach the market at all. In this presentation, we will discuss two analytical methods which are applied to the characterisation of OINDPs in order to speed up development of new and generic  products.

Lecturer: Peter Gimeson, Biosciences Field Application  Manager; Malvern Panalytica

Abstract: During the life history of a commercial therapeutic protein product, DSC analysis is uniquely valuable from early discovery research to commercial product management. DSC is a powerful tool for comparing the stability of potential drug candidates; conducting pre-formulation and formulation screening studies; biophysical characterization of drug product for regulatory filings; comparability studies after a manufacturing change; and comparing a biosimilar to an innovator drug product. DSC analysis of a protein also can provide insightful data in investigations of the roles of specific domains in the instability and aggregation of multidomain proteins.  In this webinar, the technology will be introduced and case studies will be presented, to demonstrate how DSC analysis is used in these applications.

Lecturer: Günther Spinnler, International Headquarters; Metrohm AG  

Abstract:  Data integrity requires data to be complete, consistent, and accurate throughout Their complete lifecycle, thus providing full transparency and traceability. OMNIS system compliance provides all necessary features for achieving Data integrity and compliance to FDA 21 CFR part 11 and EudraLex, Vol.4, Annex 11. In this presentation, we show which comprehensive features OMNIS has implemented to fulfill all these ambitious requirements for the Pharmaceutical  Industry

Lecturer: Adi Ben-Yaakov Head of Applications &  Development Department;  Dr. Golik Scientific Solutions

Abstract:  Powder processing lies at the heart of pharmaceutical manufacture. It is, therefore, necessary that efforts to improve efficiency and preserve quality must focus on understanding and controlling powder behavior. When it comes to effective powder characterization for process-related investigations, it’s essential to generate data that is measured under the same conditions of stress and strain that the powder experiences in the process environment such as wet granulation, die filling, tablet manufacture, screw feeders, Dry Powder Inhaler (DPI), etc.

Lecturer: Boris Katz, Regulation expert

Lecturer: Darina Rozen

Lecturer: Yael Twig & Omey Nadler

Lecturer: Stuart Wakefield; Malvern Panalytical

Lecturers: Tomer Haham & Omry Nadler

Lecturer: Darina Rozen & Tomer Haham

Lecturer: Joseph Willmot; H.E.L. Group

Wednesday 14:00 16.12.2020

H.E.L will highlight the key benefits and principles of calorimetry testing in regards to battery and cell development. They will discuss where and why to use each testing technique and show real examples of how this has helped characterize cells and thus aid in cell development

Lecturer: Martijn van Dijk; Metrohm Autolab

Monday 14.12.2020 14:00

• Introduction to batteries

• Parameters, units, vocabulary

• Li-ion batteries

• NOVA 2 in battery application

• Hardware in battery applications

• Accessories in battery applications

Lecturers: Omer Shenkman & Stuart Wakefield

Tuesday 15.12.2020 10:00AM 

The Lithium-ion battery is an energy storage device capable of almost continuous charging and discharging. In comparison to traditional battery technologies, lithium-ion batteries provide significantly higher performance and efficiency in terms of application. The power density, safety, recharge time, cost, and other aspects of its technology are expected to continue to advance.

During this talk, we will present important properties for improving battery performance. Some of these properties are particle size and shape, surface area, density, porosity, and pore size distribution.  We will discuss how these properties affect battery performance and how their measurement techniques are being implemented. Examples from electrode analysis, separator\binder evaluation, and finally manufacturing and failure analysis will be presented.

Lecturer: Omri Nadler

העולם עובר לשימוש באנרגיה ירוקה וכחלק מהתהליך הוקמו תחנות כח העובדות על גז במקום פחם. אחת הבקרות הנדרשות בתחנה היא ניטור מים וסריקת אלמנטים. בהרצאה תערך סקירה של מדידות סוגי המים שניתן לבצע בטכנולוגיית ICP-OES המשמשת למציאת אלמנטים ויוצגו מחקרים שנעשו בתחום על ידי חברת Agilent

Lecturer: Omer Shenkman

Lecturer: Sharon Sharabi

Lecturer: Yael Shaked

Lecturer: Omri Nadler

Lecturer: Dr. Jan Wülfken

Lecturer: Omer Shenkman

Lecturer: Omer Shenkman

Lecturer: Omri Nadler